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MAA 2023-40: China: Updated Measures for the Administration of the Registration of Infant and Young Children Milk Powder Formula Recipes

Date of issue:  29 September2023

Date of effect:  01 October 2023

Reference Number: MAA2023-40

Attention:

Industries—Industry bodies – Dairy Australia – Infant Nutrition Council

Export dairy establishments

Exporters

Department of Agriculture, Fisheries and Forestry — Central and Regional offices

Purpose:

To provide updated information on China’s updated Measures for the Administration of the Registration of Infant and Young Children Milk Powder Formula Recipes

Summary of key points

This Market Access Advice (MAA) informs of China’s State Administration for Market Regulation (SAMR) Order No. 80 of 2023 advising of an update to the Measures for the Administration of the Registration of Infant and Young Children Milk Powder Formula Recipes. This Order shall supersede CFDA Order No.26-2016.

These updated regulations will come into force from 1 October 2023. Points of interest include:

Article 5 confirms the State Administration for Market Regulation (SAMR) Food Review Centre’s responsibilities for the acceptance, technical review, on-site inspection, and delivery of certificates for product formula registration of formula milk powder for infants and young children. The Centre will organise experts to discuss and verify formula registrations on an as-needed basis.

Article 7 provides additional information encouraging research and innovation.

Article 8 broadens reference to applicants to specifically include overseas producers intending to export formula milk powder for infants and young children to the People’s Republic of China.

Reference is made under this Article to situations where a private entity or group has an independent research and development institution, the subsidiary company can use research and development capabilities of the group.

Article 16 clarifies the circumstances required for on-site inspections such as where significant changes occur in the composition of the product formula or where the production location has changed.

Article 21 lists eight circumstances where registration will not be granted. This list includes where the applicant does not have the capabilities for research and development, production or testing that are compatible with the product formula applied for registration.

Article 34 states when the product name contains the words “of [specific animal] origin,” the product’s raw milk, milk powder, whey powder, and other milk protein sources shall come exclusively from this species.

Article 37 also specifies prohibited language and images on labels such as language implying the product has the effect of increasing immunity, balancing intestinal flora or improving intelligence. Terms such as “imported milk source,” “originated from foreign pastures,” “ecological pastures,” and “non-polluted milk source” may not be used.  The images of infants or women may not be used.

The department has taken the new infant formula requirements on face value and is not in a position to expand on how the Chinese Authorities may interpret these standards, either through audit or through the assessment of any new or renewal of infant formula applications. It is our expectation that the approach and interpretation will be similar to existing processes and requirements.

Manufacturers and exporters are encouraged to work closely with their importers in China to further understand and clarify the required changes and avoid and misunderstanding or non-compliances with the updated infant formula standard.

Attachment

Download

Attachment 1 – USDA Report Number CH2023-0107 Titled, Revised Administrative Measures for Product Formula Registration of Infants and Young Children Formula Milk Powder (PDF 465 KB)

If you have difficulty accessing these files, visit web accessibility for assistance.

This report provides an unofficial translation of the revised Measures.

Further information

Contact exportstandards@aff.gov.au if you have any queries.

__________________________________________________________________________________

The information provided in this advice is current at the time of writing and is intended for use as guidance only and should not be taken as definitive or exhaustive. The Commonwealth endeavours to keep information current and accurate, however, it may be subject to change without notice. Exporters are encouraged to verify these details with their importers prior to undertaking production/exports. The Commonwealth will not accept liability for any loss resulting from reliance on information contained in this notice.

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Page last updated: 29 September 2023

We acknowledge the continuous connection of First Nations Traditional Owners and Custodians to the lands, seas and waters of Australia. We recognise their care for and cultivation of Country. We pay respect to Elders past and present, and recognise their knowledge and contribution to the productivity, innovation and sustainability of Australia’s agriculture, fisheries and forestry industries.

Artwork: Protecting our Country, Growing our Future
© Amy Allerton, contemporary Aboriginal Artist of the Gumbaynggirr, Bundjalung and Gamilaroi nations.

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